FDA 510(k)

VITROS 免疫诊断产品胰岛素校准器

K号: K171168 · 2017-05-16

决定日期2017-05-16

产品代码JIT

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

VITROS Immunodiagnostic Products Insulin Calibrators is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2017-05-16 under 510(k) number K171168. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VITROS Immunodiagnostic Products Insulin Calibrators?

VITROS Immunodiagnostic Products Insulin Calibrators is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K171168.

When did VITROS Immunodiagnostic Products Insulin Calibrators receive FDA 510(k) clearance?

VITROS Immunodiagnostic Products Insulin Calibrators received FDA 510(k) clearance on 2017-05-16, under 510(k) number K171168.

Who is the listed applicant for VITROS Immunodiagnostic Products Insulin Calibrators?

The FDA 510(k) record lists Ortho Clinical Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITROS Immunodiagnostic Products Insulin Calibrators?

The FDA product code for VITROS Immunodiagnostic Products Insulin Calibrators is JIT.

列明Ortho Clinical Diagnostics为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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